Clinical Operations Assistant

Responsibilities

• Support site activation by assisting with vendor system access, staff training follow-ups, and coordinating the shipment of Investigator’s Site Files and equipment.
• Manage the Trial Master File (TMF) with high quality, including timely document uploads and maintaining the Expected Document List (EDL).
• Contribute to project maintenance by providing data to clinical leadership and tracking trial progress via CTMS updates.
• Assist with site maintenance, investigator payment management, and addressing identified site issues to ensure inspection readiness.
• Support project close-out activities, including equipment return coordination and assisting with database lock procedures.
• Ensure strict compliance with ICH-GCP guidelines, local regulatory requirements, and company SOPs.

Requirements

• Strong computer skills, including proficiency in MS Office (Excel, Word, PowerPoint, Outlook) and internet navigation.
• Knowledge of Clinical Trial Management Systems (CTMS) and Electronic Document Management Systems (EDMS).
• Excellent organizational skills with the ability to manage multiple tasks and meticulous attention to detail.
• Strong command of written and spoken English.
• Ability to work independently while knowing when to escalate issues for guidance.
• Relevant qualification or equivalent experience; a high school diploma is required, while a degree in life sciences is preferred.

Preferred Qualifications

• Previous clinical research experience (e.g., Study Coordinator or Clinical Trial Assistant).
• Experience in office management within an international environment.

Benefits

• Access to a flexible work program designed to meet personal needs.
• Opportunities for professional and personal development through career advancement programs.
• A supportive company culture that prioritizes employee well-being and recognition.

About the Company

Parexel is a global clinical research organization dedicated to putting patients at the heart of every clinical trial. With a global footprint and a massive team of clinical operations professionals, we work to bring innovative medical treatments to patients faster through excellence and empathy.